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Natural Products Association Grants Current Good Manufacturing Practices Certification to Natrol
Monday, November 09, 2009 2:09 PM


2009 Audit of Natrol is Based on Compliance to NPA cGMP StandardIncorporating New Food and Drug Administration Regulations for DietarySupplements

Nov. 9, 2009 (Business Wire) -- Natrol, Inc., a premier marketer, manufacturer, and distributor of nationally branded nutritional products, has been recently certified by the Natural Products Association (“NPA”) Current Good Manufacturing Practices (“cGMP”) Certification Program which incorporates the Food and Drug Administration final (“FDA”) cGMP rule [21 CFR 111].

“This certification gives Natrol great pride in knowing that the company’s product manufacturing process meets NPA cGMP standards which now incorporates the Food and Drug Administration’s new regulations for dietary supplements,” says Jenia G. Khudagulyan, Natrol’s Senior Vice President of Operations. She continues, “The NPA cGMP certification also serves as added confidence for consumers and retailers who rely on Natrol’s reputation for quality products that are in FDA compliance.”

With a leadership role in promoting quality standards, NPA developed proactive, self-regulatory programs for this purpose, and was the first organization to offer a third-party GMP certification program specific to the manufacturing of dietary supplements and dietary ingredients. The NPA established Association GMP standards for dietary supplements in 1999, and updated this standard in 2000. At time of publication, these GMP standards represented the industry’s best practices and served as the basis for the NPA cGMP Certification Program while also establishing a higher level of control than was currently required by the Food and Drug Administration (“FDA”).

In June 2007, the FDA published the final cGMP regulation specific to dietary supplements (21 CFR 111). In order to keep the NPA GMP Certification program relevant and reflect the highest level of industry good manufacturing practices, the NPA GMP Standard has been revised to include all of the FDA GMP requirements of 21 CFR Part 111 and certain requirements from the 2000 version of the NPA GMP standard that exceed requirements of the FDA GMPs, or reflect best industry practices, and/or are necessary for the evaluation of compliance to the NPA GMP standard.

The NPA cGMP Certification Program is based upon comprehensive third-party inspections of the manufacturing facilities, including on-site audits, and cGMP-related documentation to verify compliance to the requirements of NPA cGMP standards.




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